Personalised medicine provides optimal treatment

In personalised medicine, patients are treated with medicinal products according to their individual characteristics, such as genetic background, instead of a traditional one-size-fits-all approach. Genetic screening of patients for effective and safe treatment with medicinal products is performed using in vitro diagnostic devices (IVDs), including genetic tests. Therefore, in personalised medicine, medicinal products and IVDs are linked. However, different regulatory frameworks exist for these two components of personalised medicine. The current RIVM report states that in order to adequately control the risks of personalised medicine, the legislation of medicinal products and that of IVDs should be linked. Also, RIVM research reveals that the training of healthcare professionals in the use of personalised medicine techniques needs to be improved.

Legislation gaps

The report describes the gaps between two sets of legislation.
One of these gaps is the incompleteness and lack of uniformity of
information in the summary of product characteristics (SPC) of
medicinal products, the instructions for use of the IVDs and Dutch clinical
practice guidelines. The need for comprehensive and uniform
information across these documents was confirmed by Dutch
healthcare professionals. A potential hazard resulting from lack of
(uniform) information occurs when in daily practice an IVD is used
that differs from the one applied in the pivotal clinical trials of
the medicinal product. A difference in IVD tests may result in a
different selection of patients, and thereby different, and
potentially less optimal, treatment. In addition, legislation does
not cover the simultaneous development of a medicinal product and
IVD. Finally, the results of vigilance activities (the monitoring
of adverse drug reactions, product defects, etc.) are not exchanged
between the authorities responsible for medicinal products and
those responsible for IVDs. In the European Commission's
September 2012 proposal for revised IVD regulation, both medicinal
products and IVDs
are mentioned; however, gaps remain.